NCT04197336已完成不适用
Bariatric Embolization of Arteries With Imaging Visible Embolics
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Body Weight as Assessed by BMI (kg/m^2)
研究概览
简要总结
The BEATLES study is an investigator-initiated, prospective, double-blinded, randomized, sham-controlled study that will assess the impact of bariatric embolization on the systemic levels of obesity-related hormones and, as a consequence, on weight loss. The goal of this study is to help treat obesity combining a lifestyle program and a minimally invasive, angiographic (i.e., through blood vessels) approach.
详细描述
The BEATLES study is an investigator-initiated, prospective, double-blinded, randomized, sham-controlled study that will assess the impact of bariatric embolization on the systemic levels of obesity-related hormones and, as a consequence, on weight loss. The goal of this study is to help treat obesity combining a lifestyle program and a minimally invasive, angiographic (i.e., through blood vessels) approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All participants in the pilot will receive study intervention
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged ≥21 and ≤70 years
- •Willing, able, and mentally competent to provide written informed consent
- •Obese patients with a BMI ≥35 kg/m2
- •Weight ≤400 lb
- •Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist is amendable to bariatric embolization, as assessed via 3D CT angiography
- •Suitable for protocol therapy, as determined by the interventional radiology investigator
- •Adequate hematologic (neutrophils>1.5x109/L, platelets>70x109/L, international normalized ratio (INR<1.5), hepatic (bilirubin≤2.0mg/dL, albumin≥2.5g/L), and renal (estimated glomerular filtration rate (GFR)>60milliliter mL/min. 1.73m2) function
- •For females of reproductive potential: agreement to use of highly effective contraception
- •for duration of study participation
- •Patients who have failed conservative weight loss therapies such as supervised low calorie diets combined with behavior therapy and exercise
- •Live or work within 65 miles of the enrolling institution in case a catastrophic post embolization event occurs
排除标准
- •hemoglobin A1c greater than 8%
- •Patients who are currently taking either Insulin or sulfonylurea (medication changes are allowed)
- •Prior history of gastric, pancreatic, hepatic, and/or splenic surgery
- •Prior radiation therapy to the upper abdomen
- •Prior embolization to the stomach, spleen, or liver
- •Cirrhosis
- •Known portal venous hypertension
- •Active peptic ulcer disease
- •Significant risk factors for peptic ulcer disease, including daily NSAID use
- •Large hiatal hernia, defined as >5 cm in size
- •Active H. Pylori infection
- •Known aortic pathology, such as aneurysm or dissection
- •Renal insufficiency, as evidenced by an estimated glomerular filtration rate of <60 milliliter(mL)/min
- •Major comorbidity, such as active cancer, significant cardiovascular disease, or peripheral arterial disease
- •Pregnancy
- •Pre-existing chronic abdominal pain
- •Positive stool occult blood study
- •GI bleeding or bleeding diathesis within 5 years
- •Weight loss (intentional or unintentional) of more than or equal to 5% of body weight in the 6 months prior to randomization
- •A weight loss greater than 6lb during the weight management run- in
- •Use of anti-obesity medications in the 12 months prior to screening
- •Endoscopic findings that would preclude bariatric embolization (at the discretion of the study team)
- •History of gastric motility disorders or an abnormal nuclear gastric motility examination (to be performed in diabetic subjects only)
- •American Society of Anesthesiologists Class 4 or 5 (very high risk surgical candidates: class 4=incapacitating disease that is a constant threat to life) at the time of screening for enrollment into the study - this exclusion criterion exists, because of the possibility that surgical intervention will be needed if the study intervention subsequently leads to severe adverse effects
- •Inflammatory bowel disease
- •Autoimmune disease or HIV+
- •History of allergy to iodinated contrast media
- •Failure to comply with pre-procedure weight management "run-in", or other pre-procedural visits (specifically, participants must complete 80% of weight management and Lose It! Food tracking, and 100% of one-time visits, i.e. MRI, computed tomography angiography (CTA), endoscopy)
- •Applicability of any contraindication regarding patient's vasculature as per Instruction for Use
- •Inability to have an MRI scan (i.e., metal implants or claustrophobia)
- •Smokers/vape users/tobacco use
- •Active or new-onset endocrine disorders (stable disease acceptable)
- •Other unforeseen conditions that may make patients unsuitable for the procedure (study team discretion)
- •Exclusion Criteria (Psychiatric):
- •As determined by clinical judgment based on Clinical Interview, psychological/behavioral measures, medical records, previous mental health records/other collateral information (as available) and consistent with diagnostic and statistical manual of mental disorders (DSM) -5 criteria:
- •Diagnosis of severe mental illness (i.e., chronic psychotic spectrum disorders, clinically significant mood disorders) AND/OR one or more of the following:
- •Evidence of active relapse or active impairing symptoms (e.g., suicidal ideation, audio or visual hallucinations, paranoia, thought disturbance, severe impairment)
- •Evidence of minimal supports or limited adherence to ongoing mental health care
- •Failure to provide comprehensive aftercare plan that includes emergency plan for addressing future mental health relapse
- •History of treatment refractory mental illness/recurrent relapse (multiple suicide attempts or inpatient psychiatric hospitalizations in the past 5 years)
- •Within past 3 years: Inpatient psychiatric hospitalization
- •Within past 5 years: Suicide attempt
- •Declining to provide mental health records, a letter of support from mental health professionals, or consent for verbal consultation with mental health professionals when determined to be essential to evaluation.
- •Cognitive impairment, if judged to have
- •Limited capacity to make informed decision about procedure and inability to verbalize an understanding of the surgical procedure, risks and benefits.
- •Inability to demonstrate an understanding of the permanency of lifestyle change required
- •History of Anorexia or History of/Active Bulimia: If determined to be of low enough severity not to be a clear contraindication, minimum of 5 years abstinence from bulimia, current moderate to severe binge eating or night eating syndrome
- •Active or History of Substance Abuse with less than 5 years of abstinence
- •Current use of anti-tricyclic anti-depressants or steroids, psychiatric medications associated with weight gain.
结局指标
主要结局
Change in Body Weight as Assessed by BMI (kg/m^2)
时间窗: 12 months
Efficacy of Bariatric Embolization procedure assessed by change in body weight as assessed by BMI.
Change in Body Weight (Pounds)
时间窗: 12 months
Efficacy of Bariatric Embolization procedure assessed by change in body weight (pounds)
次要结局
未报告次要终点
研究者
研究点 (2)
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